# FDA 483 - Edlaw Pharmaceutical, Inc. - November 27, 2019

Source: https://www.globalkeysolutions.net/records/483/edlaw-pharmaceutical-inc/920d7f2b-2b35-44c5-98d9-dd93dd4821ba

> FDA 483 for Edlaw Pharmaceutical, Inc. on November 27, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edlaw Pharmaceutical, Inc.
- Inspection Date: 2019-11-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Edix Pharmaceutical, Inc., a medical device repackager and relabeler in Farmingdale, NY, revealed significant deficiencies in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and did not perform quality internal audits at defined intervals. These issues indicate a lack of adequate controls for adverse event reporting and overall quality system oversight.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/edlaw-pharmaceutical-inc/a5b70704-23f8-4adb-ae55-2f769d7a67e4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961